Study of Cilofexor in Adults With Primary Sclerosing Cholangitis

PHASE3TerminatedINTERVENTIONAL
Enrollment

419

Participants

Timeline

Start Date

March 27, 2019

Primary Completion Date

November 10, 2022

Study Completion Date

December 23, 2022

Conditions
Primary Sclerosing Cholangitis
Interventions
DRUG

Cilofexor

100 mg tablet administered orally once daily

DRUG

Placebo

Tablet administered orally once daily

Trial Locations (201)

1090

Allgemeines Krankenhaus Wien, Vienna

2001

Waikato Hospital, Hamilton

2010

St. Vincent's Hospital Sydney, Darlinghurst

2050

Royal Prince Alfred Hospital, Camperdown

2145

Westmead Hospital, Westmead

2650

Universitair Ziekenhuis Antwerpen, Edegem

2751

Nepean Hospital, Penrith

3004

The Alfred Hospital, Melbourne

3010

Hospital General Universitario de Alicante, Alicante

Universitatsspital Bern, Bern

3050

The Royal Melbourne Hospital, Parkville

3084

Austin Health, Heidelberg

3168

Monash Health, Clayton

4000

Centre Hospitalier Universitaire de Liège Site Sart Tilman, Liège

4025

Hopital Robert Debré - Centre Hospitalier Universitaire de Reims, Reims

4029

Royal Brisbane and Women's Hospital, Herston

4066

Coral Sea Clinical Research Institute - Mackay, Auchenflower

4101

Mater Misericordiae Ltd, South Brisbane

6000

Royal Perth Hospital, Perth

6009

Sir Charles Gairdner Hospital, Nedlands

6900

Epatocentro Ticino SA, Lugano

8011

Christchurch Hospital, Christchurch

8091

Universitatsspital Zurich, Zurich

9000

Algemeen Ziekenhuis Maria Middelares, Ghent

Universitair Ziekenhuis Gent, Ghent

Aalborg University Hospital, Aalborg

9020

Landeskrankenanstalten-Betriebsgesellscaft - KABEG, Klinikum Klagenfurt am Wörthersee, Klagenfurt

10016

NYU Langone Health, New York

10021

Weill Cornell Medical College, New York

10029

Icahn School of Medicine at Mount Sinai Beth Israel, New York

Mount Sinai Medical Center, New York

10032

Center for Liver Disease and Transplantation, Columbia University Medical Center, New York

10070

Hôpital Erasme - ULB, Brussels

10467

Montefiore Medical Center, The Bronx

10825

GASTRO-Studien GbR, Berlin

11030

Northwell Health Center for Liver Diseases and Transplantation, Manhasset

13008

Hôpital Saint-Joseph, Marseille

14642

University of Rochester Medical Center, Rochester

15706

Hospital Clinico Universitario Santiago de Compostela, Santiago de Compostela

17033

Penn State Health Milton S. Hershey Medical Center, Hershey

19107

Thomas Jefferson University, Philadelphia

19141

Einstein Medical Center, Philadelphia

19611

Reading Hospital, West Reading

20007

MedStar Georgetown University Hospital, Washington D.C.

20089

U.O.C. Gatroenterologia, Rozzano

Istituto Clinico Humanitas - Unita Operativa di Epatologia, Rozzano (Milan)

20122

Ca'Granda Ospedale Maggiore Policlinico UOC Gastroenterologia ed Epatologia, Milan

20520

Turku University Hospital, Gastroenterology Outpatient Clinic, Turku

20889

Walter Reed National Military Medical Center, Bethesda

21202

Mercy Medical Center, Baltimore

22031

Verity Research Inc., Fairfax

22908

University of Virginia Medical Center, Charlottesville

23226

Bon Secours Richmond Community Hospital, Richmond

23298

Virginia Commonwealth University Clinical Research Services Unit, Richmond

24146

Gastroenterologisch-Hepatologisches Zentrum Kiel, Kiel

27157

Wake Forest Baptist Health, Winston-Salem

27599

The University of NC at Chapel Hill, Clinical and Translational Research Center (CTRC), Chapel Hill

27710

Duke University Medical Center, Durham

28006

Hospital Universitario de la Princesa, Madrid

28034

Hospital Universitario Ramon y cajal, Madrid

28046

Hospital Universitario La Paz, Madrid

28100

Medicina Interna 1, Novara

28204

Carolinas Medical Center - Center for Liver Disease, Charlotte

Medical University of South Carolina, Charleston

28220

Hospital Universitario Puerta de Hierro Majadahonda, Majadahonda

30309

Piedmont Atlanta Hospital, Atlanta

30625

Medizinische Hochscule Hannover, Hanover

31059

CHU de Toulouse Hopital Ranguiel, Toulouse

31096

Rambam Health Care Campus, Haifa

31300

CHU de Toulouse - Hopital Rangueil, Toulouse

32127

Advanced Medical Research Center, Port Orange

33136

Schiff Center for Liver Diseases/University of Miami, Miami

33331

Cleveland Clinic Florida, Weston

33604

CHU Bordeaux-Hopital Haut-Leveque, Pessac

34295

Hôpital Saint-Eloi, Montpellier

34653

Advanced Research Institute, Inc, New Port Richey

35128

Azienda Ospedale Universita Padova, Padua

36071

Complejo Hospitalario de Pontevedra, Pontevedra

37232

Vanderbilt University Medical Center - Digestive Disease Center, Nashville

38043

CHU Grenoble Alpes, Grenoble

38104

Methodist University Hospital, Memphis

39157

Southern Therapy and Advanced Research LLC, Jackson

40138

Azienda Ospedaliero Universitaria di Moderna, Ospedale di Baggiovara, Bologna

45147

Universitätsklinikum Essen, Essen

45267

Holmes Hospital, Cincinnati

46010

Hospital General Universitario de Valencia, Valencia

46026

Hospital Universitari Politecnic La Fe de Valencia, Valencia

46202

IU Health University Hospital, Indianapolis

48109

Yale School of Medicine, New Haven

Michigan Medicine - University of Michigan, Ann Arbor

48202

Henry Ford Hospital, Detroit

49100

Rabin Medical Center, Petah Tikva

50009

Hospital Universitario Miguel Servet, Zaragoza

55117

Minnesota Gastroenterology, PA, Maplewood

55131

Universitatsmedizin der Johannes Gutenberg-Universitat Mainz, Mainz

55905

Mayo Clinic, Rochester

56124

Azienda Ospedaliero-Universitaria Pisana - Unità Operativa Epatologia, Pisa

57701

Rapid City Medical Center, LLP, Rapid City

59000

Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez, CHRU Lille

60126

Dipartimento Gastroenterologico e dei Trapianti, Ancona

60201

NorthShore University Healthsystem, Evanston

60590

Universitätsklinikum Frankfurt, Frankfurt am Main

60611

Northwestern Memorial Hospital; Clinical Research Unit, Chicago

60612

Rush University Medical Center, Chicago

60637

University of Chicago Medical Center (outpatient clinic), Chicago

62431

Tel Aviv Sourasky Medical Center, Tel Aviv

63104

Saint Louis University, Gastroenterology & Hepatology, St Louis

64239

Shaare Zedek Medical Center, Jerusalem

66160

University of Kansas Hospital, Kansas City

66421

Universitätsklinikum des Saarlandes, Klinik für Innere Medizin II, Gastroenterologie und Hepatologie, Homburg

67091

CHU de Strasbourg - Nouvel Hôpital Civil, Strasbourg

68105

University of Nebraska Medical Center, Omaha

68167

Universitätsmedizin Mannheim, II. Medizinische Klinik, Mannheim

69120

Universitätsklinik Heidelberg, Heidelberg

70121

Ochsner Clinic Foundation, New Orleans

71013

IRCCS Ospedale Sollievo della Sofferenza, San Giovanni Rotondo

71105

Louisiana Research Center, LLC, Shreveport

75203

The Liver Institute at Methodist Dallas Medical Center, Dallas

75246

Annette & Harold C. Simmons Transplant Institute @ Baylor University Medical Center at Dallas, Dallas

75571

Hopital Saint Antoine, Paris

76012

Texas Clinical Research Institute, Arlington

76104

Baylor Scott & White Medical Center at Fort Worth, Fort Worth

77030

Baylor College of Medicine - Advanced Liver Therapies, Houston

77338

Spring Gastroenterology Associates, Humble

78234

San Antonio Military Medical Center, Gastro/Hepatology, San Antonio

80045

University of Colorado Denver and Hospital, Aurora

80054

CHU Amiens-Picardie Hôpital Sud, Amiens

80113

South Denver Gastroenterology, PC, Englewood

80907

Peak Gastroenterology Associates, Colorado Springs

84107

Intermountain Medical Center - Transplant Services, Murray

84132

University of Utah Hospital, Salt Lake City

85013

The Institute for Liver Heath, Phoenix

85306

Institute For Liver Health, Glendale

90036

Ruane Clinical Research Group Inc., Los Angeles

90048

Cedars Sinai Medical Center, West Hollywood

90127

Azienda Ospedaliera Universitaria Policlinico P. Giaccone, Palermo

91105

California Liver Research Institute, Pasadena

91120

Hadassah University Hospital Ein Kerem, Jerusalem

92037

Altman Clinical and Translational Research Institute (Clinic), La Jolla

Scripps Clinic/Green Hospital, La Jolla

92103

Auckland City Hospital, Auckland

92118

Southern California Research Center, Coronado

94010

Hôpital Henri Mondor, Créteil

94025

Stanford Hospital, Palo Alto

94107

Sutter Pacific Medical Foundation - California Pacific Medical Center, San Francisco

94143

University of California, San Francisco Liver Clinic, San Francisco

94800

Hopital Paul Brousse, Villejuif

95817

University of California, Davis Medical Center (study visits), Sacramento

98101

Virginia Mason Medical Center, Seattle

98104

Harborview Medical Center, Seattle

98105

Liver Institute Northwest, Seattle

1834111

Emek Medical Center, Afula

5265601

The Chaim Sheba Medical Center, Ramat Gan

7008558

Okayama University Hospital, Okayama

7348551

Hiroshima University Hospital, Hiroshima

9909585

Yamagata University Hospital, Yamagata

02114

Massachusetts General Hospital, Boston

02215

Beth Israel Deaconess Medical Center, Boston

02721

NECCR PrimaCare Research, LLC, Fall River

07103

Rutgers New Jersey Medical School - Doctors Office Center, Newark

02905

University Gastroenterology, Providence

05401

The University of Vermont Medical Center, Burlington

B-3000

Universitair Ziekenhuis Leuven, Leuven

L6R 3J7

William Osler Health System - Brampton Civic Hospital, Brampton

T2N 4Z6

University of Calgary Liver Unit - Heritage Medical Research Clinic (HMRC), Calgary

T6G 2X8

University of Alberta Hospital - Walter C. Mackenzie Health Sciences Centre (WMC), Edmonton

B3L 1E4

Queen Elizabeth II Health Sciences Centre, Nova Scotia Health Authority, Halifax

L8N 4A6

St. Joseph's Healthcare Hamilton, Hamilton

L8S 4L8

McMaster University Medical Center, Hamilton

H2X 3J4

Centre de Recherche du Centre Hospitalier de l'Université de Montréal (CRCHUM), Montreal

H4A 3J1

Chronic Viral Illness Service/McGill University Health Centre (MUHC), Montreal

M5G 2C4

Toronto General Hospital - Toronto Centre for Liver Disease (TCLD), Toronto

M6H 3M1

Toronto Liver Centre, Toronto

V5Z 1M9

Gordon and Leslie Diamond Health Care Centre, Vancouver General Hospital, UBC Division of Gastroenterology, Vancouver

V6Z 2K5

(G.I.R.I.) GI Research Institute, Vancouver

R3E 3P4

University of Manitoba/Health Sciences Centre, Winnipeg

DK-2100

Copenhagen University Hospital - Hvidovre, København Ø

00290

Helsinki University Hospital, Endoscopy Unit, Gastroenterology Outpatient clinic, Meilahden tomisairaala, Helsinki

04103

Universitätsklinikum Leipzig AöR, Leipzig

Unknown

Carmel Medical Center, Haifa

The Leeds Teaching Hospitals NHS Trust, Leeds

00168

Fondazione Policlinico Universitario Agostino Gemelli, Rome

260-8670

Chiba University Hospital, Chiba

856-8562

National Hospital Organization Nagasaki Medical Center, Nagasaki

980-8574

National University Corporation Tohoku University Tohoku University Hospital, Sendai

565-0871

Osaka University Hospital, Suita

113-8431

Juntendo University Hospital, Tokyo

173-8606

Teikyo University Hospital, Tokyo

791-0295

Ehime University Hospital, Toon-Shi

08035

Hospital Universitari Vall d'Hebron, Barcelona

B15 2TT

University Hospital Birmingham NHS Foundation Trust, Birmingham

CB2 0QQ

Cambridge University Hospitals NHS Foundation Trust, Cambridge

G4 0SF

NHS Greater Glasgow and Clyde, Glasgow

L9 7AL

Aintree University Hospitals NHS Foundation Trust, Liverpool

E1 1BB

Barts Health NHS Trust, London

NW3 2QG

Royal Free London NHS Foundation Trust, London

SE5 9NT

King's College Hospital NHS Foundation Trust, London

SW10 9NH

Chelsea and Westminster Hospital NHS Foundation Trust, London

NG7 2UH

Nottingham University Hospitals NHS Trust, Nottingham

OX3 9DU

Oxford University Hospitals NHS Foundation Trust, Oxford

PO6 3LY

Portsmouth Hospitals NHS Trust, Portsmouth

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY